is the sorting process of tablets and capsules mandatory or optional regarding the guidelines ?
if mandatory please refer to guide
thanks
Hi Mohamed, and welcome.
It is always important that you establish in-process controls to ensure that your process is under statistical control and in low risk of manufacturing out of specification (OOS) product. This is an essential GMP related activity included as a direct regulatory requirement:
CFR 21 part 211.110 Sampling and testing of in-process materials and drug products.
(a) To assure batch uniformity and integrity of drug products, written procedures shall be established and followed that describe the in-process controls, and tests, or examinations to be conducted on appropriate samples of in-process materials of each batch. Such control procedures shall be established to monitor the output and to validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product. Such control procedures shall include, but are not limited to, the following, where appropriate:
(1) Tablet or capsule weight variation;
(2) Disintegration time;
(3) Adequacy of mixing to assure uniformity and homogeneity;
(4) Dissolution time and rate;
(5) Clarity, completeness, or pH of solutions.
(6) Bioburden testing.